A study to assess the effects of a platelet inhibitor (zalunfiban). This platelet inhibitor is given by a single subcutaneous injection. Targeted patients are patients with an acute myocardial infarction. The medication will be given in the ambulance. Subsequently a coronary angiography will be perormed and if needed the patient will be treated with primary coronary angioplasty

A Phase 3 prospective, blinded, randomized, placebo controlled, international multicenter study to assess the safety and efficacy of a single subcutaneous injection of zalunfiban in subjects with ST-elevation myocardial infarction in the pre-hospital setting - CELEBRATE

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-003320-16-NL

Enrollment

2499

Registered

2020-09-02

Start date

2020-12-23

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subjects with documented STEMI, presenting with persistent ischemic chest pain (>10 minutes) and new =2 mm ST-segment elevation in 2 adjacent ECG leads, in whom the total duration of symptoms to diagnostic ECG is anticipated to be within 4 hours. MedDRA version: 20.0 Level: HLGT Classification code 10028593 Term: Myocardial disorders System Organ Class: 10007541 - Cardiac disorders MedDRA version: 20.0 Level: PT Classification code 10000891 Term: Acute myocardial infarction System Organ Class:

Interventions

Product Name: zalunfiban Product Code: 140962 Pharmaceutical Form: Solution for injection INN or Proposed INN: zalunfiban Current Sponsor code: RUC-4 Other descriptive name: GLYCOPROTEIN IIB/IIIA Conc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Planned transport to participating clinical site - Males aged =18 years or post-menopausal or surgically sterile females =50 years or =55 years (for Czech Republic study sites only). - Weight (by history) between 52 and 130 kg (115 and 287 lb). - Subjects with documented STEMI, presenting with persistent ischemic chest pain (>10 minutes) and new =2 mm ST-segment elevation in 2 adjacent ECG leads, in whom the total duration of symptoms to diagnostic ECG is 4 hours maximum. - Enrollment by EFIC process, verbal witnessed/short written informed consent, or written informed consent will be obtained in the acute phase by (para)medics [Romania and other select sites with the sponsor’s approval: clinical site personnel, if greater than 30 minutes of delay is anticipated for door-to-balloon time]. Subject is willing and able to give informed consent. Written informed consent will be obtained as soon as the subject’s clinical condition allows it. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1000 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1499

Exclusion criteria

Exclusion criteria: - Cardiopulmonary Resuscitation for current Out of Hospital Cardiac Arrest. - Cardiogenic shock presenting with systolic blood pressure 100 beats per minute. - Current known active coronavirus disease 2019 (COVID-19) infection (criteria according to local guidelines. - Currently treated with renal dialysis. - Current treatment with oral anticoagulation (Vitamin K antagonists* or direct oral anticoagulants**) and thrombolytic agents***. For example. * acenocoumarol or phenprocoumon, fluindione, and Coumadin (warfarin) ** dabigatran, apixaban, edoxaban, rivaroxaban, and betrixaban *** tenecteplase, alteplase, reteplase, streptokinase, and urokinase - Major surgery, or trauma or bleeding leading to hospitalization, within the past month. - Known history of ischemic or hemorrhagic stroke. - Known severe anemia (regular blood transfusion needed). - Previously enrolled in this study. - Participation in another clinical study with an investigational product or device within the past month. - Life expectancy less than one year.

Design outcomes

Primary

Measure	Time frame
Main Objective: Efficacy: - To assess the clinical outcome at 30-day follow-up after administration of a single subcutaneous injection of zalunfiban versus placebo in STEMI subjects in the pre-hospital setting. Safety: - To assess bleeding events (according to Global Use of Strategies to Open Occluded Coronary Arteries [GUSTO] severe or life threatening criterion for safety assessment and, for information only, according to the Bleeding Academic Research Consortium [BARC] Types 3C and 5 criteria after a single subcutaneous injection of zalunfiban versus placebo at 30-day follow-up. ;Secondary Objective: To assess after a single s.c. injection of zalunfiban vs placebo: Efficacy: -Restoration of the culprit coronary artery blood flow of the Culprit before intended PCI (or post-CAG in case no PCI performed) -Resolution of ST-segment deviation post-PCI/CAG - Blinded bail-out use of IV aIIbß3 receptor antagonists or IV P2Y12 antagonist at 24 hours post-PCI/angiography Safety: -Safety throughout study -Platelet count pre-PCI/CAG, post-PCI/CAG, 6hr post-PCI/CAG, 24hr post-PCI/CAG and at discharge/72hr post-PCI (whichever occurs first) - Bleeding events at 30 day FU: - According to ISTH Major - According to GUSTO mild and moderate criteria, BARC Types 2, 3, and 5 criteria, ISTH minor and/or major bleeding, and TIMI minor and major criteria) -The injection site reactions of a single s.c. injection of zalunfiban versus placebo at baseline, 1hr post-PCI/CAG, hospital discharge/72hr post-PCI/CAG, and at 30-day FU;Primary end point(s): Efficacy: To assess after a single subcutaneous injection of zalunfiban versus placebo: Clinical outcome as assessed by a 7-point scale. The 7 outcomes, ranking from worst to best, are: a. Death (all cause) at 30-day follow-up b. Stroke at 30-day follow-up c. Recurrent MI (Types 1 to 4 MI) at 30-day follow-up d. Acute stent thrombosis at 24 hours post-PCI/angiography e. New onset HF or re-hospitalization for HF at 30-day follow-up f. M	—

Measure

Time frame

Main Objective: Efficacy: - To assess the clinical outcome at 30-day follow-up after administration of a single subcutaneous injection of zalunfiban versus placebo in STEMI subjects in the pre-hospital setting. Safety: - To assess bleeding events (according to Global Use of Strategies to Open Occluded Coronary Arteries [GUSTO] severe or life threatening criterion for safety assessment and, for information only, according to the Bleeding Academic Research Consortium [BARC] Types 3C and 5 criteria after a single subcutaneous injection of zalunfiban versus placebo at 30-day follow-up. ;Secondary Objective: To assess after a single s.c. injection of zalunfiban vs placebo: Efficacy: -Restoration of the culprit coronary artery blood flow of the Culprit before intended PCI (or post-CAG in case no PCI performed) -Resolution of ST-segment deviation post-PCI/CAG - Blinded bail-out use of IV aIIbß3 receptor antagonists or IV P2Y12 antagonist at 24 hours post-PCI/angiography Safety: -Safety throughout study -Platelet count pre-PCI/CAG, post-PCI/CAG, 6hr post-PCI/CAG, 24hr post-PCI/CAG and at discharge/72hr post-PCI (whichever occurs first) - Bleeding events at 30 day FU: - According to ISTH Major - According to GUSTO mild and moderate criteria, BARC Types 2, 3, and 5 criteria, ISTH minor and/or major bleeding, and TIMI minor and major criteria) -The injection site reactions of a single s.c. injection of zalunfiban versus placebo at baseline, 1hr post-PCI/CAG, hospital discharge/72hr post-PCI/CAG, and at 30-day FU;Primary end point(s): Efficacy: To assess after a single subcutaneous injection of zalunfiban versus placebo: Clinical outcome as assessed by a 7-point scale. The 7 outcomes, ranking from worst to best, are: a. Death (all cause) at 30-day follow-up b. Stroke at 30-day follow-up c. Recurrent MI (Types 1 to 4 MI) at 30-day follow-up d. Acute stent thrombosis at 24 hours post-PCI/angiography e. New onset HF or re-hospitalization for HF at 30-day follow-up f. M

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Secondary

Measure	Time frame
Secondary end point(s): Efficacy: To assess after a single subcutaneous injection of zalunfiban versus placebo: - As assessed by an independent Core Laboratory: Corrected TIMI Frame Count of the Infarct-Related Artery (Culprit) before PCI/angiography - As assessed by an independent Core Laboratory: ST-segment deviation resolution 1-hour post-PCI/angiography - Blinded bail-out use of IV aIIbß3 receptor antagonists or IV P2Y12 antagonists at 24 hours post-PCI/angiography Safety To assess after a single subcutaneous injection of zalunfiban versus placebo: - Recording of AEs and SAEs: AEs up to 30-day follow-up; SAEs up to resolution/stabilization, the SAEs mortality and hospitalization for HF and atrial fibrillation up to 12-months follow-up - Platelet count before PCI/angiography, at the end of the PCI/angiography, 6 and 24 hours post-PCI/angiography, and at hospital discharge/72-hours post-PCI/angiography (whichever occurs first) - Subject incidence of bleeding events (according to ISTH Major and, for information only, TIMI Major) at 30 days follow-up - Subject incidence of bleeding events according to GUSTO mild and moderate criteria, BARC Types 2, 3, and 5 criteria, ISTH minor and/or major bleeding, and TIMI minor and major criteria at 30-day follow-up - Subject incidence of injection site reactions at baseline, 1-hour post-PCI/angiography, hospital discharge/72-hours post- PCI/angiography, and at 30-day follow-up;Timepoint(s) of evaluation of this end point: see secondary end points (E.5.2)	—

Measure

Time frame

Secondary end point(s): Efficacy: To assess after a single subcutaneous injection of zalunfiban versus placebo: - As assessed by an independent Core Laboratory: Corrected TIMI Frame Count of the Infarct-Related Artery (Culprit) before PCI/angiography - As assessed by an independent Core Laboratory: ST-segment deviation resolution 1-hour post-PCI/angiography - Blinded bail-out use of IV aIIbß3 receptor antagonists or IV P2Y12 antagonists at 24 hours post-PCI/angiography Safety To assess after a single subcutaneous injection of zalunfiban versus placebo: - Recording of AEs and SAEs: AEs up to 30-day follow-up; SAEs up to resolution/stabilization, the SAEs mortality and hospitalization for HF and atrial fibrillation up to 12-months follow-up - Platelet count before PCI/angiography, at the end of the PCI/angiography, 6 and 24 hours post-PCI/angiography, and at hospital discharge/72-hours post-PCI/angiography (whichever occurs first) - Subject incidence of bleeding events (according to ISTH Major and, for information only, TIMI Major) at 30 days follow-up - Subject incidence of bleeding events according to GUSTO mild and moderate criteria, BARC Types 2, 3, and 5 criteria, ISTH minor and/or major bleeding, and TIMI minor and major criteria at 30-day follow-up - Subject incidence of injection site reactions at baseline, 1-hour post-PCI/angiography, hospital discharge/72-hours post- PCI/angiography, and at 30-day follow-up;Timepoint(s) of evaluation of this end point: see secondary end points (E.5.2)

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Countries

Canada, Czechia, Czech Republic, France, Hungary, Netherlands, Romania, United States

Contacts

Public ContactS. Postma

Diagram BV

s.postma@diagram-zwolle.nl003138426 2999

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026